The following data is part of a premarket notification filed by Gynecare, Inc. with the FDA for Gynecare Versapoint G-vap Electrode.
| Device ID | K992901 |
| 510k Number | K992901 |
| Device Name: | GYNECARE VERSAPOINT G-VAP ELECTRODE |
| Classification | Hysteroscope (and Accessories) |
| Applicant | GYNECARE, INC. P.O. BOX 151 Sommerville, NJ 08876 -0151 |
| Contact | Gregory Jones |
| Correspondent | Gregory Jones GYNECARE, INC. P.O. BOX 151 Sommerville, NJ 08876 -0151 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-30 |
| Decision Date | 2000-01-18 |
| Summary: | summary |